藥物臨床試驗(yàn)研究者視角下的受試者權(quán)益保護(hù)情況調(diào)查研究——以北京某三甲醫(yī)院藥物臨床試驗(yàn)機(jī)構(gòu)的調(diào)查研究為例
發(fā)布時間：2018-10-20 07:53
【摘要】：目的:了解受試者權(quán)益保護(hù)的實(shí)施現(xiàn)狀,探索分析可能的影響因素并提出相應(yīng)的建議。方法:以藥物臨床試驗(yàn)機(jī)構(gòu)的研究者作為調(diào)查對象,通過對北京某三甲醫(yī)院藥物臨床試驗(yàn)機(jī)構(gòu)中取得藥物臨床試驗(yàn)質(zhì)量管理規(guī)范的醫(yī)護(hù)人員進(jìn)行現(xiàn)場問卷調(diào)研,共發(fā)放問卷150份,回收138份,運(yùn)用SPSS 17.0進(jìn)行數(shù)據(jù)統(tǒng)計(jì)分析。結(jié)果:調(diào)查發(fā)現(xiàn),藥物臨床試驗(yàn)受試者權(quán)益保護(hù)情況整體較好。但研究者因臨床任務(wù)重、接受培訓(xùn)不充分、藥物臨床試驗(yàn)研究性質(zhì)與臨床治療性質(zhì)的區(qū)別等原因,導(dǎo)致受試者權(quán)益保護(hù)方面仍有一定欠缺,尤其是受試者的知情同意權(quán)和隱私權(quán)的保護(hù)有進(jìn)一步完善和嚴(yán)謹(jǐn)?shù)谋匾�。結(jié)論:針對這些問題,結(jié)合調(diào)查者的意見,研究建議通過改制設(shè)崗、明確立法、加強(qiáng)監(jiān)管以及強(qiáng)化培訓(xùn)等措施來加強(qiáng)對藥物臨床試驗(yàn)受試者權(quán)益的保護(hù)。
[Abstract]:Aim: to understand the present situation of the protection of subjects' rights and interests, to explore and analyze the possible influencing factors and to put forward corresponding suggestions. Methods: a questionnaire survey was carried out among the medical staff who obtained the quality management standard of the drug clinical trial in a third class hospital in Beijing by taking the researchers of the drug clinical trial institution as the investigation object. A total of 150 questionnaires were sent out, 138 were recovered, and SPSS 17.0 was used for statistical analysis. Results: the results showed that the protection of subjects' rights and interests was better in clinical trials. However, due to the heavy clinical tasks, inadequate training, the difference between the nature of drug clinical trial research and the nature of clinical treatment, there are still some deficiencies in the protection of the rights and interests of the subjects. Especially, the right of informed consent and the protection of privacy are necessary. Conclusion: in view of these problems and combined with the opinions of the investigators, the study suggests that the protection of the rights and interests of the subjects in clinical trials of drugs should be strengthened through the measures of reforming the system and setting up the post, making clear the legislation, strengthening the supervision and strengthening the training.
【作者單位】： 首都醫(yī)科大學(xué)附屬北京地壇醫(yī)院;首都醫(yī)科大學(xué);
【分類號】：R969.4
[Abstract]:Aim: to understand the present situation of the protection of subjects' rights and interests, to explore and analyze the possible influencing factors and to put forward corresponding suggestions. Methods: a questionnaire survey was carried out among the medical staff who obtained the quality management standard of the drug clinical trial in a third class hospital in Beijing by taking the researchers of the drug clinical trial institution as the investigation object. A total of 150 questionnaires were sent out, 138 were recovered, and SPSS 17.0 was used for statistical analysis. Results: the results showed that the protection of subjects' rights and interests was better in clinical trials. However, due to the heavy clinical tasks, inadequate training, the difference between the nature of drug clinical trial research and the nature of clinical treatment, there are still some deficiencies in the protection of the rights and interests of the subjects. Especially, the right of informed consent and the protection of privacy are necessary. Conclusion: in view of these problems and combined with the opinions of the investigators, the study suggests that the protection of the rights and interests of the subjects in clinical trials of drugs should be strengthened through the measures of reforming the system and setting up the post, making clear the legislation, strengthening the supervision and strengthening the training.
【作者單位】： 首都醫(yī)科大學(xué)附屬北京地壇醫(yī)院;首都醫(yī)科大學(xué);
【分類號】：R969.4
【參考文獻(xiàn)】
相關(guān)期刊論文 前3條
1 田少雷,曹彩;臨床試驗(yàn)研究者的資格和職責(zé)[J];中國醫(yī)藥導(dǎo)刊;2000年04期
2 邵蓉;張s，
本文編號：2282524
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